GE Healthcare Revolution CT user interface fails to confirm scan group addition
The GE Healthcare Revolution CT system's user interface fails to update and confirm when scan group names are added using certain characters. This configuration defect requires a software fix to ensure proper scan group setup.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II software/user interface defect in a medical device that could lead to improper scan configuration. No injuries or illnesses are reported in the source. The core scanning functionality remains operational, but the defect prevents proper user confirmation of scan group addition, creating a risk of configuration errors.
Plain-English summary
The GE Healthcare Revolution CT computed tomography system is subject to a Class II FDA recall. The system's user interface fails to properly update and confirm when users add scan group names containing characters other than letters, numbers, or spaces. This defect means the interface will not provide the visual confirmation that a scan group has been successfully added to the acquisition.
This user interface malfunction creates a potential for improper scan group configuration, as operators may be unaware that their intended scan groups were not successfully added to the system due to the lack of confirmation feedback.
The recall affects Revolution CT systems distributed in the US. Affected users should contact GE Healthcare for remediation instructions.
The recalled product
- Product
- The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles. The system has the capability to image whole organs in a single rotation. Whole organs includ
- Manufacturer
- GE Healthcare, LLC
- Hazard
- software-malfunction
- configuration-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Revolution CT
Distribution
Distribution scope not specified by the agency.
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